COBAS EGFR MUTATION TEST
FDA premarket approval P120019/S004 · decided 2014-03-12
Approval details
- PMA number
- P120019
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COBAS EGFR MUTATION TEST
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche
- Date received
- 2013-12-13
- Decision date
- 2014-03-12
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Peasanton, CA
- Statement
- APPROVAL FOR CHANGES TO THE COBAS 4800 SR2 SYSTEM SOFTWARE ARCHITECTURE AND ASSAY SPECIFIC ANALYSIS PACKAGE (ASAP) SOFTWARE FOR THE COBAS BRAF V600 MUTATION TEST AND COBAS EGFR MUTATION TEST.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HOMOCYSTEINE TEST (K113793) | Roche | 2012-06-05 |
| TQ HBA1C GEN3 (K102914) | Roche | 2011-01-20 |